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TERMINATED

NCT03870451

Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

This trial studies how well cryocompression therapy works in reducing bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Peripheral neuropathy (nerve pain or tingling in hands or feet) is a common side effect of chemotherapy such as bortezomib that affects the quality of life and amount of chemotherapy that can be given to many cancer patients. Cryocompression is a treatment where a glove and a boot are worn to cool down the skin. This cooling treatment is safe and does not interfere with chemotherapy treatment. Daily cryocompression therapy may reduce neuropathy caused by bortezomib chemotherapy.

Official title: Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-11-01

Completion Date

2023-02-10

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Chemotherapy-induced Peripheral Neuropathy Plasma Cell Myeloma

Interventions

DEVICE

VascuTherm5 vascular compression device

VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device

Inclusion Criteria: * Patients must have histologically or cytologically confirmed multiple myeloma (any International Staging System \[ISS\] stage). * Clinical symptoms of bortezomib-induced peripheral neuropathy as measured by the NCI-CTCAE. Cohort 1: Patients with clinically documented CTCAE grade greater than or equal 2 neuropathy. Cohort 2: Patients with clinically documented CTCAE grade 1-2 neuropathy. • Currently or previously received bortezomib-containing regimen Cohort 1: Patients who have previously received a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen. Cohort 2: Patients who are currently receiving a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen. * Age must be greater than or equal to 18 years. * Eastern Cooperative Oncology Group (ECOG) =\< 4. * Life expectancy \>= 6 months. * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document. Exclusion Criteria: * Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of bortezomib therapy. * Other explanatory etiology for neuropathy. * Presumptive evidence of congestive heart failure. * Current deep vein thrombosis or pulmonary embolism (diagnosed within the past 6 months). * Current pulmonary edema. * Unable to provide accurate medical history. * Pregnant women are excluded from this study because they will not be receiving myeloma standard of care (SOC) therapy or bortezomib-based therapy per inclusion criteria. * Current or previously documented inflammatory phlebitis; thrombophlebitis; decompensated cardiac insufficiency; arterial dysregulation; erysipelas; carcinoma or carcinoma metastasis in the affected extremity; decompensated hypotonia; venous or arterial occlusive disease; or Raynaud's disease; * Current monoclonal gammopathy of undetermined significance (MGUS), Waldenstroms macroglobulinemia, or Castleman disease.

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States